Federal regulators "banning" a specific person from an industry is rare. 23 and Me didn't receive anything close to this type of regulation, scrutiny, and public accusations. Theranos may not be a perfect company, but it's likely some powerful people are pulling strings to snub them out for an agenda that supersedes regulation.
Regulators Propose Banning Theranos Founder from Blood Testing
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Re: Regulators Propose Banning Theranos Founder from Blood Testing
#92At what point does the fraud become criminal?
Based on intent, people being effected, and those people or others complaining about it/going to litigation.
Re: Regulators Propose Banning Theranos Founder from Blood Testing
#93At what point does the fraud become criminal?
When it violates a criminal statute.
Re: Regulators Propose Banning Theranos Founder from Blood Testing
#94That sounds oddly specific ...
Re: Regulators Propose Banning Theranos Founder from Blood Testing
#95Direct link to letter from CMS to Theranos with proposed sanctions and justification for sanctions:
http://online.wsj.com/public/resources/documents/cms20160412...
Re: Regulators Propose Banning Theranos Founder from Blood Testing
#96Earlier quoted context omitted.
Bill Frist is a medical doctor and has focused on healthcare policy throughout his career, for whatever that's worth.
Umm, the good doctor's wealth comes from HCA, a chain of for-profit hospitals that once held the record for the largest fraud settlement in US history. Frist clearly has excellent PR, because very few people ever mention this. http://www.forbes.com/2000/12/15/1215disaster.html
>Frist clearly has excellent PR, because very few people ever mention this.
Reminiscent of Peter Thiel and Clarium Capital (no fraud there, but tremendous losses). No one ever talks about it.
Re: Regulators Propose Banning Theranos Founder from Blood Testing
#97Earlier quoted context omitted.
Bull Shit. Biotech companies produce more MVP's then any other sector. Just because we don't need to test if the business will work (as much as say a facebook) we do need to test the science. My startup is working on infection resistant materials for around hospitals. Infections are a problem, if we solve it we will have customers, how many and at what cost is the question. But because science is the question, and it…
Correct me if I'm wrong but I thought one of the key ideas of a MVP is that it's something you put in the hands of customers to get feedback on. How many of those 1,000s have you given to customers?
> I thought one of the key ideas of a MVP is that it's something you put in the hands of customers...
Internet-type startups, at their core, are about marketing more than they are about technology. Getting the technology right is absolutely no guarantee of success, but you can hack together some PHP and -- if you get the marketing right -- make a shitload of money.
Psychology is kinda hard to do rigorously, so you test marketing the only place you really can -- in the market.
Conversely, the question "does this material prevent infections?" can actually be studied, to a significant extent, in controlled lab experiments. You don't need the marketplace to answer that question.
And for many cases -- such as the OP's -- it's obvious that if the answer is "yes" then you have a valuable product. Period. End of story. Infection-resistant materials aren't a fucking social network. If they work, they are obviously and immediately useful. You'll need to get the business side right, but it's really less difficult than the science itself because hospitals are begging for products to buy that address this problem.
So the question is more "can we solve this totally obviously extant and well-defined and obviously significant problem" rather than "have we identified a problem whose solution will let us win some pocket change of a big number of consumers?"
Figuring out if the science works out IS the MVP test. If you have a product that works your customers will be lining up.
Re: Regulators Propose Banning Theranos Founder from Blood Testing
#98Earlier quoted context omitted.
It's more like the method of drawing the blood was thought to be the problem. A venous draw is going to be pretty clean, in that whatever tissue got stuck in the aperture of the needle is going to be dwarfed by the quantity of blood taken; I've read that the actual assaying machines use very little of the blood, which makes sense because the reagents used are expensive, plus to the extent you're using optical scannin…
> A venous draw is going to be pretty clean, in that whatever tissue got stuck in the aperture of the needle is going to be dwarfed by the quantity of blood taken From the many blood draws I have done, standard practice is to fill a tosser vial before collecting the real samples in order to remove these contaminants.
From the ones done on me for bog standard tests in the last dozen years or more, that wasn't done, but the extra gunk in the vial just might be intended to grab the contaminants as well as stabilize the blood. Or maybe these more standard tests allow for whatever amount of contamination is in the drawn blood, suppose it's 2-3 orders of magnitude less.
Re: Regulators Propose Banning Theranos Founder from Blood Testing
#99"One of those tests, a blood-coagulation test known as prothrombin time, measures how long it takes blood to clot and is often used by doctors to determine which dosage of the blood thinner warfarin to give patients.
Wrong prothrombin time results could cause doctors to prescribe too little or too much warfarin. Too much of the drug, also known by its brand name Coumadin, can cause fatal bleeding, while too little can leave patients vulnerable to clots and strokes, according to medical experts."
Huge free market failure here. Thank god we still have some working government regulation in this country.
Re: Regulators Propose Banning Theranos Founder from Blood Testing
#100Earlier quoted context omitted.
> The research models have performed as they always have, if not better. I'm not an expert on the history of progress in medical research... however, I do have a medical degree. Bottom line, I have higher standards and think we could be doing a lot better. Regardless, without counterfactual data it's really a very subjective question.
If you haven't seen it, this a pretty interesting and controversial paper: Increasing disparities between resource inputs and outcomes, as measured by certain health deliverables, in biomedical research http://www.pnas.org/content/112/36/11335.full Basically, increased funding of biomedical research hasn't resulted in better output, and that we do, indeed, need to change the model. The current model is really ineffic…
I don't think that paper clearly shows that. It could also be that the low hanging fruit has been taken, and that, as we reach for ever more hard to reach fruits, the effort needed per unit of health improvement necessarily increases.
Another explanation could be that the money givers haven't gotten as much health improvements as they would want because they haven't directly asked for them, as this paper acknowledges:
"A recent focus on productivity has dominated the competitive evaluation of scientists, creating incentives to maximize publication numbers, citation counts, and publications in high-impact journals. [...] The efficiency of society’s investments in biomedical research, in terms of improved health outcomes, has not been studied."
Computer programmers do not produce more profitable programs if you pay programmers by lines of code, either.